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Implementing Shared Decision Making in Interprofessional Home Care Teams (IPSDM-SW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02592525
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : December 20, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
France Legare, CHU de Quebec-Universite Laval

Study Description
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Brief Summary:

This study will train health providers in home care teams across Quebec in shared decision making about the decision to stay at home or move to another location. This decision is one of the toughest for older Canadians. Decisions that are informed, shared and supported produce better results. An interprofessional approach to shared decision making is when older persons and their caregivers are supported by not just one but by all the professionals involved in their care.The impact of the training program in interprofessional shared decision making (IPSDM) above that of the passive dissemination of a decision guide will be assessed by measuring to what extent older persons caregivers say they took active part in the decision-making process.

Other outcome measures will be:

i) what option they chose, whether they feel conflict or regret about their decision, and the burden of care they feel; ii) the quality of life of clients;


Condition or disease Intervention/treatment Phase
Aging Behavioral: IP-SDM training for health professionals Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 653 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementing Shared Decision Making in Interprofessional Home Care Teams : a Stepped Wedge Cluster Randomized Trial
Actual Study Start Date : November 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cluster A
IP-SDM training for health professionals (intervention at 4 months)
 Behavioral: IP-SDM training for health professionals
Multifaceted SDM training program for providers: i) 1.5-hour online tutorial, ii) 3.5-hour skills building workshop; iii) video-clip demonstrating SDM in the context of an IP home care team with an aging adult making a decision about location of care (to be used with clients and providers as well); and iv) performance feedback to providers (role play during the workshop).
Experimental: Cluster B
IP-SDM training for health professionals (intervention at 11 months)
 Behavioral: IP-SDM training for health professionals
Multifaceted SDM training program for providers: i) 1.5-hour online tutorial, ii) 3.5-hour skills building workshop; iii) video-clip demonstrating SDM in the context of an IP home care team with an aging adult making a decision about location of care (to be used with clients and providers as well); and iv) performance feedback to providers (role play during the workshop).
Experimental: Cluster C
IP-SDM training for health professionals (intervention at 18 months)
 Behavioral: IP-SDM training for health professionals
Multifaceted SDM training program for providers: i) 1.5-hour online tutorial, ii) 3.5-hour skills building workshop; iii) video-clip demonstrating SDM in the context of an IP home care team with an aging adult making a decision about location of care (to be used with clients and providers as well); and iv) performance feedback to providers (role play during the workshop).
Experimental: Cluster D
IP-SDM training for health professionals (intervention at 25 months)
 Behavioral: IP-SDM training for health professionals
Multifaceted SDM training program for providers: i) 1.5-hour online tutorial, ii) 3.5-hour skills building workshop; iii) video-clip demonstrating SDM in the context of an IP home care team with an aging adult making a decision about location of care (to be used with clients and providers as well); and iv) performance feedback to providers (role play during the workshop).


Outcome Measures
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Primary Outcome Measures :
  1. Assumed Role in decision making [ Time Frame: 7 months ]
    To assess the proportion of caregivers reporting an active role, a modified version of the Control Preferences Scale designed to assess the role assumed in the decision making process will be used. The scale consists of a single question and is the one most frequently used in studies assessing the implementation of SDM in clinical practice.


Secondary Outcome Measures :
  1. Patient involvement in decision making [ Time Frame: 7 months ]
    Assessed with the Dyadic-OPTION scale, a 12-item self-administered instrument that assesses 12 specific SDM behaviours during the decision-making process

  2. Decisional Regret [ Time Frame: 7 months ]
    Assessed with the Decisional Regret Scale

  3. Decisional Conflict [ Time Frame: 7 months ]
    Assessed with the Decisional Conflict Scale

  4. Health-related quality of life [ Time Frame: 7 months ]
    Assessed with two subscales (Social isolation and Emotional reactions) of the HR-QoL questionnaire from the Nottingham Health Profile, clients only

  5. Burden of care [ Time Frame: 7 months ]
    Assessed with the Zarit Burden Inventory Scale (ZBI), caregivers only

  6. Preferred and chosen option (remain at home or move to another location) [ Time Frame: 7 months ]
    Questionnaire assessing the prefered and chosen option


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Clients or caregivers of clients :

  • Aged ≥65 years;
  • Receiving care from the IP home care team of the enrolled CISSS/CIUSSS
  • Have made a decision about whether to stay at home or move to another location during the recruitment periods
  • Are able to read, understand and write French or English
  • Can give informed consent

In the case clients are not able to provide informed consent, their caregiver will be eligible.

Exclusion Criteria:

  • Clients who are not able to provide informed consent and who don't have a caregiver
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592525


Locations
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Canada, Quebec
Centre de recherche sur les soins et les services de première ligne de l'Université Laval (CERSSPL-UL)
Québec, Quebec, Canada, G1J 0A4
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: France Légaré, Ph. D. Laval University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: France Legare, Canada Research Chair in Implementation of Shared Decision Making in Primary Care, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02592525    
Other Study ID Numbers: 2015-2016 01-01-E
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019